font size

Sangamo BioSciences presented data demonstrating that human CD4 T-cells can be made permanently resistant to HIV infection by treatment with its zinc finger DNA-binding protein nucleases and preferentially survive and expand in an animal after HIV infection. The Richmond, California-based Sangamo’s zinc finger protein nucleases are designed to permanently modify the DNA sequence encoding CCR5, a co-receptor that enables HIV to enter and infect cells of the immune system. Individuals carrying a naturally occurring mutation of their CCR5 gene, a variant known as CCR5-delta32, have been shown to be resistant to HIV infection. Sangamo’s technology represents a means of potentially circumventing the limitations or risks drugs that target CCR5 by specifically modifying only CD4 T-cells, the principal target of HIV pathology, in a one-time exposure of the cells to zinc finger protein nucleases. This results in permanent modification of the CCR5 protein so that HIV cannot enter and infect the cells. This approach could potentially enable the generation of a reservoir of protected CD4 T-cells that are available to fight the opportunistic infections that are characteristic of AIDS as well as the AIDS virus itself.

 

The Juvenile Diabetes Research Foundation said it entered a partnership with South San Francisco, California-based CoMentis to support the biotechnology company’s human clinical trial of ATG3, a topical eye drop therapy for diabetic macular edema. Diabetic macular edema is a serious complication of diabetes that can lead to vision loss. The partnership will accelerate the clinical trials of CoMentis’ drug, which will enter a mid-stage trial during the third quarter. ATG3, a proprietary formulation of mecamylamine that is also in development for the treatment of age-related macular degeneration, is an antagonist of the nicotinic acetylcholine receptor pathway that may counter balance the vascular leak and angiogenesis of diabetic macular edema.

 

In a study to be published in the journal Analytical Chemistry, researchers at Stanford University said a using a variation of polymerase chain reaction—a process for amplifying minute amounts of DNA, they could reduce the time for convention prenatal testing for Down’s Syndrome from two weeks to two hours. The shortened time could benefit parents, for whom the long wait can be difficult due to anxiety. The process known as digital polymerase chain reaction was performed in a commercially available microfluidic chip. The technique enabled researchers to confirm the presence of abnormal chromosomes typical of Down syndrome with great accuracy. Rapid testing alternatives already exist, but they are either too labor-intensive or not applicable to the whole population. The researchers said this approach overcomes these limitations and called the new test “rapid and simple.”

 

Research conducted at the University of California, San Diego School of Medicine has shed new light on the structure and function of one of the key proteins in all mammalian cells, protein kinase A or PKA. PKA is an enzyme that plays an essential role in memory formation, communication between nerve cells, and cardiac function. Utilizing a process called x-ray crystallography, the scientists solved the structure of the large PKA complex, revealing a totally new structure that shows PKA’s ability to function as a scaffold that supports and controls the release of chemicals involved in transmitting signals. The structure is shown with the study in the journal Cell. When PKA somehow stays on, its prolonged activation can lead to cardiac disease and breast cancer. Discovery of the enzyme’s molecular structure may help researchers design drugs that specifically block the protein kinase activity involved in cancer or cardiac disease. 

 

Despite the huge publicity generated by a 2002 study on the potential dangers of hormone therapy for postmenopausal women, new research from the Stanford University School of Medicine found that only 29 percent of women surveyed knew about the study two years later. Additionally, the women were able to correctly identify the possible benefits and risks linked to hormone therapy just 40 percent of the time. Few research studies have had the impact on public health recommendations as the 2002 results reported by the Women’s Health Initiative, the longest-ever examination of the health of postmenopausal women. Those findings were the subject of unprecedented media coverage and triggered enormous changes in the use of hormone therapy. The new Stanford study, published in the journal Menopause, suggests that the medical profession hasn’t yet figured out an effective way of communicating crucial health information to patients.

 

Sanofi-Aventis said it initiated a 500-patient late-stage clinical trial of its angiogenesis therapy, which is based on San Diego-based Vical’s non-viral DNA delivery technology. Assuming successful completion of the trial, Sanofi-Aventis expects to file for marketing approval in 2010. The plasmid DNA therapy encodes Fibroblast Growth Factor 1, a growth factor that stimulates the growth of blood vessels, and is intended to reduce the need for amputations in patients suffering from critical limb ischemia. Critical limb ischemia is a severe and costly condition. In the twelve months following the first episode of critical limb ischemia, 55 percent of patients either require amputation or die. In the United States and Europe, there are more than 150,000 amputations each year due to critical limb ischemia, with a direct cost of nearly $6 billion and a total cost of more than $8 billion. Sanofi-Aventis previously reported results from a mid-stage trial in 107 patients demonstrating a statistically significant reduction in the rate of both major amputations and all amputations in patients receiving NV1FGF compared with those receiving placebo.

 

Alexza Pharmaceuticals said it expects to begin the first of two late-stage trials for its drug AZ-004 (Staccato loxapine) late in the first quarter of 2008. That puts the Palo Alto, California-based company six to 12 months ahead of schedule. AZ-004 is initially being developed for the treatment of acute agitation in patients with schizophrenia or bipolar disorder. AZ-004 is the combination of Alexza’s proprietary Staccato system with loxapine, a drug belonging to the class of compounds known as antipsychotics. AZ-004 combines drug delivery speed comparable to that of an intravenous injection, but with the simplicity of a simple, one-breath inhalation. 

 

A review of six publicly available hospital comparison web sites suggests that they display inconsistent results and use inappropriate or incomplete standards to measure quality, according to a report in the Archives of Surgery. A total of 113 million Americans searched for health information on the Internet in 2006. Of those, 29 percent searched for information on specific hospitals and physicians. Data on hospital performance is frequently made available through web sites aimed at patients, but few researchers have examined these sites and their content. Researchers at the David Geffen School of Medicine at UCLA, Los Angeles found significant inconsistencies—for example, for colon removal, one hospital was ranked best by two sites, but worst by another site, and the hospital ranked best on that site was ranked worst on another. The researchers said further work is needed to improve these issues, particularly the accessibility by patients, the quality and type of data reporting, the statistical method, and the criteria by which hospitals and specific operations are compared.

 

Irvine, California-based Allergan, Inc. said it entered into an agreement to acquire privately held Esprit Pharma for $370 million in cash. Esprit, based in East Brunswick, New Jersey, specializes in genitourinary products and currently markets Sanctura, a treatment for overactive bladder. Allergan currently anticipates launching Sanctura in the first quarter of 2008. Allergan will retain and increase the size of Esprit's sales organization, currently 160 representatives, and will create a dedicated genitourinary division to serve urologists and their patients.

 

Evotec said it will acquire South San Francisco, California-based Renovis in a stock-for-stock transaction valued at approximately $151.8 million. The merger is expected to create an emerging global pharmaceutical company with three clinical candidates, a strong late stage preclinical pipeline focusing on areas of neurological and inflammatory diseases. By the end of 2008, the combined company expects to have at least five compounds in clinical trials.